Systolic Blood PressureNCT07349706
IMST for Dementia Risk Reduction
A study testing Inspiratory Muscle Strength Training High-Resistance and Inspiratory Muscle Strength Training Low-Resistance in people with Systolic Blood Pressure and Blood Pressure, run by Florida State University at 1 site in United States.
Trial summary
Using a 2-arm, RCT approach, the primary goal of the study is to evaluate the feasibility and preliminary efficacy of Inspiratory Muscle Strength Training (IMST) as a non-pharmacologic intervention to reduce cardiovascular and cognitive risks in older adults. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Systolic Blood Pressure, Blood Pressure, Depression - Major Depressive Disorder
- What is being tested?
- Inspiratory Muscle Strength Training High-Resistance and Inspiratory Muscle Strength Training Low-Resistance
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 60-80
- Converted telephone MoCA total score≥18
- Presence of at least one dementia risk factor (e.g., MCI or subjective cognitive decline, hypertension [SBP >130 mmHg or on medication], sedentary lifestyle [<150 min/week], family history of dementia or self-reported APOE ε4 carrier, or mild sleep-disordered breathing; CAIDE total score [>5]
- Capable of independently completing or requiring minimal assistance with inspiratory muscle strength training (IMST)
- Willing to adhere to the IMST protocol (approximately 5-10 minutes per day for 8 weeks)
- Optional inclusion of inspiratory muscle weakness (MIP <80 cmH₂O for men, <70 cmH₂O for women) will also be assessed.
Who cannot join
- tMoCA <18, or diagnosis of neurodegenerative illness at the discretion of principal investigator (except MCI)
- Current evidence of any major psychiatric disorder including psychosis (at the discretion of principal investigator), bipolar disorder, severe major depression (PHQ-9 > 20)
- Unstable cardiovascular or pulmonary disease
- Recent respiratory therapy or major medication changes
- Self-reported severe untreated or unstable obstructive sleep apnea (OSA)
- Recent start (within the past month) of CPAP or BiPAP, or recent use of inspiratory muscle training
Show all 9Show fewer
- Lung and eardrum injuries
- Non-English speaking
- Participants with a pacemaker or other medical implants containing magnets or electronics will be noted and excluded from body composition analyses.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Florida State University
Tallahassee, Florida, 32301
Dr. Julia Sheffler, 850-644-4199, julia.sheffler@med.fsu.edu
About this study
Official title: Randomized Controlled Pilot Trial of Inspiratory Muscle Strength Training (IMST) to Reduce Dementia Risk in Older Adults
Using a 2-arm, RCT approach, the primary goal of the study is to evaluate the feasibility and preliminary efficacy of Inspiratory Muscle Strength Training (IMST) as a non-pharmacologic intervention to reduce cardiovascular and cognitive risks in older adults. Next, investigators will examine secondary effects of IMST on mood, sleep quality, systemic inflammation, and physical/motor function. Finally, investigators will assess participant adherence and acceptability ratings of using an 8-week home-based IMST protocol in a diverse older adult sample.
Read the detailed description
This is a 2-arm randomized pilot trial (N=30), including adults aged 60-80 years of age with cardiovascular risks for dementia. Participants will complete assessments prior to beginning the study, each week during the intervention, and at the conclusion of the 8-week intervention. Participants in the experimental group will complete daily high-resistance IMST training (e.g., 75% maximal inspiratory pressure), and participants in the sham condition will complete IMST training at 15% maximal inspiratory pressure. Investigators hypothesize the following: Hypothesis 1: Participants in the high-resistance IMST group will show greater reductions in systolic blood pressure and other vascular health indicators compared to those in the sham IMST group after 8 weeks.
Hypothesis 2: Participants in the high-resistance IMST group will demonstrate greater improvements in executive cognitive function than those in the sham group.
Hypothesis 3: IMST will lead to secondary improvements in mood (reduced depression and anxiety symptoms), better sleep quality (as measured by self-report and actigraphy), and improved physical function (e.g., grip strength, gait speed).
Hypothesis 4: The IMST protocol will be feasible and acceptable, with at least 80% adherence to prescribed training sessions over the 8-week period.
- Conditions
- Systolic Blood Pressure, Blood Pressure, Depression - Major Depressive Disorder, Anxiety, Sleep Quality, Physical Function
- Being tested
- Inspiratory Muscle Strength Training High-Resistance, Inspiratory Muscle Strength Training Low-Resistance
- Medical subject headings
- Anxiety Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle Strength Training High-ResistanceDevice
Investigators will use POWERbreathe® Electronic IMST devices and manually set them to 75% of an individual's IPpeak, depending on their randomization, to the high-resistance IMST group or very low-resistance IMST (sham) group. All participants will complete 30 training breaths per day at home for 8 weeks.
Inspiratory Muscle Strength Training Low-ResistanceDevice
Investigators will use POWERbreathe® Electronic IMST devices and manually set them to 15% of an individual's IPpeak, depending on their randomization, to the high-resistance IMST group or very low-resistance IMST (sham) group. All participants will complete 30 training breaths per day at home for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| High-Resistance | Experimental | Participants assigned to the high resistance arm will complete inspiratory muscle strength training (IMST) using a handheld respiratory training device set to 75% of their maximal inspiratory pressure (MIP). Participants will follow the IMST training regimen for the duration of the intervention period, 8-weeks, consisting of 30 breaths per day, completed in a minimum of 5 minutes. Receives: Device: Inspiratory Muscle Strength Training High-Resistance |
| Control Group - Low-Resistance | Sham comparator | Participants assigned to the low-resistance arm will complete inspiratory muscle strength training (IMST) using a handheld respiratory training device set to 15% of their maximal inspiratory pressure (MIP). Participants will follow the IMST training regimen for the duration of the intervention period, 8-weeks, completing 30 inspiratory breaths per day, with each session lasting a minimum of 5 minutes. Receives: Device: Inspiratory Muscle Strength Training Low-Resistance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic BP
Participants will demonstrate a change in systolic blood pressure (mmHg), assessed as the average of two seated measurements obtained following two consecutive 5-minute rest periods, from baseline to post-intervention.
Measured: Baseline, 8-weeks
Change in executive cognitive functioning
Participants will demonstrate a change in executive cognitive functioning, assessed using the Fluid Composite Score from the NIH Toolbox Cognition Battery. The Fluid Composite Score is derived from tasks assessing executive function, attention, working memory, episodic memory, and processing speed. Change in executive cognitive functioning will be evaluated as the difference in Fluid Composite Scores from baseline to post-intervention.
Measured: Baseline, 8 weeks
Secondary outcomes (7)
Change from Baseline in Mood Symptoms (Depression) at 8 Weeks
Participants will demonstrate a change in depression symptoms, assessed using the Patient Health Questionnaire-9 (PHQ-9) for depressive symptoms. Total scores of 5, 10, 15, and 20 represent cut off points for mild, moderate, moderately severe and severe depression. Change in symptoms will be evaluated as the difference in scores from baseline to 8 weeks, with higher scores indicating greater symptom severity.
Measured: Baseline, 8 weeks
Change from Baseline in Mood Symptoms (Anxiety) at 8 Weeks
Participants will demonstrate a change in anxiety symptoms, assessed using the Geriatric Anxiety Scale-10 (GAS) for anxiety symptoms. Total scores range from 0 to 30, with higher scores indicating greater symptom severity. Change in symptoms will be evaluated as the difference in scores from baseline to 8 weeks, with higher scores indicating greater severity.
Measured: Baseline, 8 weeks
Change from Baseline in Sleep Quality at 8 Weeks
Participants will demonstrate a change in sleep quality, measured using the Pittsburgh Sleep Quality Index (PSQI) and objective sleep measures collected via actigraphy (Fitbit) devices provided to participants. Change in sleep quality will be evaluated as the difference in PSQI global scores, with higher scores indicating poorer sleep quality, and sleep metrics compiled from actigraphy data from baseline to 8 weeks.
Measured: Baseline, 8 weeks
Change from Baseline in Inflammatory Markers (CRP, IL-6, TNF-α) at 8 Weeks
Participants will demonstrate a change in inflammatory markers, assessed from fasting blood samples. Serum concentrations of CRP, IL-6, and TNF-α will be measured using standardized laboratory analyses. Change in inflammatory markers will be evaluated from baseline to 8 weeks.
Measured: Baseline, 8 weeks
Change from Baseline in Physical Functioning (Grip-Strength) at 8 Weeks
Participants will demonstrate a change in physical functioning, assessed using grip strength. Change in physical functioning will be evaluated from baseline to 8 weeks based on performance across these standardized physical function measures. Higher grip strength performance indicate improved physical functioning.
Measured: Baseline, 8 weeks
Change from Baseline in Physical Functioning (Gait Speed) at 8 Weeks
Participants will demonstrate a change in physical functioning, assessed using gait speed. Change in physical functioning will be evaluated from baseline to 8 weeks based on performance across these standardized physical function measures. Faster gait speed performance indicate improved physical functioning.
Measured: Baseline, 8 weeks
Change from Baseline in Physical Functioning (Sit-to-Stand) at 8 Weeks
Participants will demonstrate a change in physical functioning, assessed using the sit-to-stand test. Change in physical functioning will be evaluated from baseline to 8 weeks based on performance across these standardized physical function measures. Improved sit-to-stand performance indicate improved physical functioning.
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start17 Nov 2025
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systolic Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Julia Sheffler, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349706
- Sponsor's protocol ID
- STUDY00006529
- Status last verified
- Oct 2026
- First submitted
- 15 Jan 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be shared to protect the privacy and confidentiality of the participants.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Pilot Trial of Inspiratory Muscle Strength Training (IMST) to Reduce Dementia Risk in Older Adults
- ClinicalTrials.gov ID
- NCT07349706
- Acronym / sponsor ID
- STUDY00006529
- Conditions
- Systolic Blood Pressure, Blood Pressure, Depression - Major Depressive Disorder, Anxiety, Sleep Quality, Physical Function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Using a 2-arm, RCT approach, the primary goal of the study is to evaluate the feasibility and preliminary efficacy of Inspiratory Muscle Strength Training (IMST) as a non-pharmacologic intervention to reduce cardiovascular and cognitive risks in older adults. Next, investigators will examine secondary effects of IMST on mood, sleep quality, systemic inflammation, and physical/motor function. Finally, investigators will assess participant adherence and acceptability ratings of using an 8-week home-based IMST protocol in a diverse older adult sample.
Detailed description
This is a 2-arm randomized pilot trial (N=30), including adults aged 60-80 years of age with cardiovascular risks for dementia. Participants will complete assessments prior to beginning the study, each week during the intervention, and at the conclusion of the 8-week intervention. Participants in the experimental group will complete daily high-resistance IMST training (e.g., 75% maximal inspiratory pressure), and participants in the sham condition will complete IMST training at 15% maximal inspiratory pressure. Investigators hypothesize the following: Hypothesis 1: Participants in the high-resistance IMST group will show greater reductions in systolic blood pressure and other vascular health indicators compared to those in the sham IMST group after 8 weeks.
Hypothesis 2: Participants in the high-resistance IMST group will demonstrate greater improvements in executive cognitive function than those in the sham group.
Hypothesis 3: IMST will lead to secondary improvements in mood (reduced depression and anxiety symptoms), better sleep quality (as measured by self-report and actigraphy), and improved physical function (e.g., grip strength, gait speed).
Hypothesis 4: The IMST protocol will be feasible and acceptable, with at least 80% adherence to prescribed training sessions over the 8-week period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Resistance | Experimental | Device: Inspiratory Muscle Strength Training High-ResistanceParticipants assigned to the high resistance arm will complete inspiratory muscle strength training (IMST) using a handheld respiratory training device set to 75% of their maximal inspiratory pressure (MIP). Participants will follow the IMST training regimen for the duration of the intervention period, 8-weeks, consisting of 30 breaths per day, completed in a minimum of 5 minutes. |
| Control Group - Low-Resistance | Sham comparator | Device: Inspiratory Muscle Strength Training Low-ResistanceParticipants assigned to the low-resistance arm will complete inspiratory muscle strength training (IMST) using a handheld respiratory training device set to 15% of their maximal inspiratory pressure (MIP). Participants will follow the IMST training regimen for the duration of the intervention period, 8-weeks, completing 30 inspiratory breaths per day, with each session lasting a minimum of 5 minutes. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ages 60-80
- Converted telephone MoCA total score≥18
- Presence of at least one dementia risk factor (e.g., MCI or subjective cognitive decline, hypertension [SBP >130 mmHg or on medication], sedentary lifestyle [<150 min/week], family history of dementia or self-reported APOE ε4 carrier, or mild sleep-disordered breathing; CAIDE total score [>5]
- Capable of independently completing or requiring minimal assistance with inspiratory muscle strength training (IMST)
- Willing to adhere to the IMST protocol (approximately 5-10 minutes per day for 8 weeks)
Key exclusion criteria (9 listed)
- tMoCA <18, or diagnosis of neurodegenerative illness at the discretion of principal investigator (except MCI)
- Current evidence of any major psychiatric disorder including psychosis (at the discretion of principal investigator), bipolar disorder, severe major depression (PHQ-9 > 20)
- Unstable cardiovascular or pulmonary disease
- Recent respiratory therapy or major medication changes
- Self-reported severe untreated or unstable obstructive sleep apnea (OSA)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory Muscle Strength Training High-ResistanceInvestigators will use POWERbreathe® Electronic IMST devices and manually set them to 75% of an individual's IPpeak, depending on their randomization, to the high-resistance IMST group or very low-resistance IMST (sham) group. All participants will complete 30 training breaths per day at home for 8 weeks. | Device | High-Resistance |
| Inspiratory Muscle Strength Training Low-ResistanceInvestigators will use POWERbreathe® Electronic IMST devices and manually set them to 15% of an individual's IPpeak, depending on their randomization, to the high-resistance IMST group or very low-resistance IMST (sham) group. All participants will complete 30 training breaths per day at home for 8 weeks. | Device | Control Group - Low-Resistance |
Primary outcome
Change in systolic BP
Time frame: Baseline, 8-weeks
Participants will demonstrate a change in systolic blood pressure (mmHg), assessed as the average of two seated measurements obtained following two consecutive 5-minute rest periods, from baseline to post-intervention.
Change in executive cognitive functioning
Time frame: Baseline, 8 weeks
Participants will demonstrate a change in executive cognitive functioning, assessed using the Fluid Composite Score from the NIH Toolbox Cognition Battery. The Fluid Composite Score is derived from tasks assessing executive function, attention, working memory, episodic memory, and processing speed. Change in executive cognitive functioning will be evaluated as the difference in Fluid Composite Scores from baseline to post-intervention.
7 secondary outcomes
Change from Baseline in Mood Symptoms (Depression) at 8 Weeks
Time frame: Baseline, 8 weeks
Change from Baseline in Mood Symptoms (Anxiety) at 8 Weeks
Time frame: Baseline, 8 weeks
Change from Baseline in Sleep Quality at 8 Weeks
Time frame: Baseline, 8 weeks
Change from Baseline in Inflammatory Markers (CRP, IL-6, TNF-α) at 8 Weeks
Time frame: Baseline, 8 weeks
Change from Baseline in Physical Functioning (Grip-Strength) at 8 Weeks
Time frame: Baseline, 8 weeks
Change from Baseline in Physical Functioning (Gait Speed) at 8 Weeks
Time frame: Baseline, 8 weeks
Change from Baseline in Physical Functioning (Sit-to-Stand) at 8 Weeks
Time frame: Baseline, 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect the privacy and confidentiality of the participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Strength Training High-Resistance and Inspiratory Muscle Strength Training Low-Resistance in people with Systolic Blood Pressure and Blood Pressure, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in systolic BP (time frame: Baseline, 8-weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.